IPQA Specialist, Sterile Injectable Manufacturing

GL Staffing; Boca Raton (FL); On-site; USD 75,000 - 95,000; Full time

Job summary

GL Staffing is seeking an In-Process Quality Assurance (IPQA) Specialist to provide real-time quality oversight on the manufacturing floor for sterile injectable products. The role ensures compliance with cGMP, approved procedures, and batch records, and serves as the quality representative during production.

Responsibilities include in-process inspections, line clearance, documentation review, deviation investigations, and CAPA support.

Qualifications

• Minimum 5–10 years of QA or IPQA experience in pharma.
• Hands-on experience with sterile injectable manufacturing.
• Proven ability to review batch records and maintain data integrity.
• Strong knowledge of cGMP and FDA/EU regulations.

Responsibilities

• Provide real-time QA oversight on the manufacturing floor.
• Inspect sterile operations: filtration, filling, stoppering, and packaging.
• Review BMR/BPR, SOPs, and ensure regulatory compliance.
• Identify deviations and support CAPA investigations and implementations.
• Collaborate with cross-functional teams and support audits.

Skills

QA Oversight

cGMP Knowledge

Aseptic Processing

Documentation Review

Education

Bachelor's degree in Pharmacy, Chemistry, Biotechnology, Microbiology

Job description

GL Staffing is seeking an In-Process Quality Assurance (IPQA) Specialist to provide real-time quality oversight on the manufacturing floor for sterile injectable products. The role ensures compliance with cGMP, approved procedures, and batch records, and serves as the quality representative during production.

Responsibilities include in-process inspections, line clearance, documentation review, deviation investigations, and CAPA support.